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JOURNAL ONKOLOGIE – STUDIE
CRANIO4US

Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners

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NCT-Nummer:
NCT04319510

Studienbeginn:
Januar 2021

Letztes Update:
03.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universität Duisburg-Essen

Collaborator:
-

Studienleiter

Gustav Dobos, Prof. MD
Study Director
Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Kontakt

Studienlocations
(1 von 1)

Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
45276 Essen
(Nordrhein-Westfalen)
Germany» Google-Maps

Studien-Informationen

Brief Summary:

Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that

aims to release restrictions of the fasciae and regulate the arousal of the sympathetic

nervous system, which is often increased in chronically ill patients. Initial randomized

trials support CST's efficacy and effectiveness in reducing symptoms of patients with

psychosomatic and chronic pain disorders. To date, there is no trial investigating the

effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in

women with breast cancer. In clinical practice, therapists also report alleviating as well as

regulating effects of simple CST self-help techniques, offered to patients within a group

concept.

Within the recent study, a CST treatment and self-help protocol for women after curative

therapy of breast cancer was developed and shall be tested against a waiting list control

group. The first group will receive 24 units of CST treatment in a 1:1 setting with a

certified craniosacral therapist over 12 weeks. The second group will receive 24 units of

group training (women with partners) in CST self-help techniques offered by a certified

craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6

months) after randomization. The third group will wait for 26 weeks and will receive no

specific study intervention. After 26 weeks patients of the third group were offered to take

part in two individual CST interventions and the CST self-help training. For all groups,

treatment as usual is allowed.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Breast cancer (stage I-III) survivors after finishing curative chemotherapy and/or

radiation

- Impaired breast caner-related quality of life (< 112,8 points on the FACT-B)

- Partner who is willig to participate in the group training

Exclusion Criteria:

- Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation

during the study period

- Pregnancy

- Simultaneous participation in other clinical trials

Studien-Rationale

Primary outcome:

1. Breast cancer-related quality of life - total score (Time Frame - week 12):
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life as a total score of 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.



Secondary outcome:

1. Breast cancer-related quality of life - sub scores (Time Frame - week 12):
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.

2. Breast cancer-related quality of life - total score (Time Frame - week 26):
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 44 self-report items (4 general subscales and one breast-cancer specific subscale, which will be summarized to a total score) and assesses the specific breast cancer-related quality of life. A higher score indicates a higher cancer-related quality of life.

3. Breast cancer-related quality of life - sub scores (Time Frame - week 26):
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.

4. Fatigue (Time Frame - week 12):
Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Questionnaire: The addoitional F-scale of the FACT consists of 13 self-report items and assesses fatigue related to cancer on 1 scale. A higher score indicates a higher cancer-related fatigue.

5. Fatigue (Time Frame - week 26):
Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Questionnaire: The addoitional F-scale of the FACT consists of 13 self-report items and assesses fatigue related to cancer on 1 scale. A higher score indicates a higher cancer-related fatigue.

6. Endocrine symptoms (Time Frame - week 12):
Funcitonal Assessment of Cancer - Endocrine Symptom (FACT-ES) Questionnaire: The additonal ES-scale of the FACT consists of 19 self-report items and assesses symptoms related to the endocrine system / antihormonal therapy on 1 scale. A higher score indicates a higher endocrine symptoms.

7. Endocrine symptoms (Time Frame - week 26):
Funcitonal Assessment of Cancer - Endocrine Symptom (FACT-ES) Questionnaire: The additonal ES-scale of the FACT consists of 19 self-report items and assesses symptoms related to the endocrine system / antihormonal therapy on 1 scale. A higher score indicates a higher endocrine symptoms.

8. Sleep disturbance (Time Frame - week 12):
Patient related outcomes measurement information system - sleep disturbance (PROMIS-SD) Short form: The SD-short form of the PROMIS consists of 8 self-report items and assesses the disturbance of sleep on 1 scale. A higher score indicates higher disturbances of the sleep.

9. Sleep disturbance (Time Frame - week 26):
Patient related outcomes measurement information system - sleep disturbance (PROMIS-SD) Short form: The SD-short form of the PROMIS consists of 8 self-report items and assesses the disturbance of sleep on 1 scale. A higher score indicates higher disturbances of the sleep.

10. Severity of insomnia (Time Frame - week 12):
Insomnia Severity Index (ISI): The ISI consists of 7 self-report items and assesses the severity of insomnia on 1 scale. A higher score indicates higher severity of insomnia.

11. Severity of insomnia (Time Frame - week 26):
Insomnia Severity Index (ISI): The ISI consists of 7 self-report items and assesses the severity of insomnia on 1 scale. A higher score indicates higher severity of insomnia.

12. State anxiety (Time Frame - week 12):
Patient related outcomes measurement information system - anxiety/emotional distress (PROMIS-A/ED) Short form: The A/ED-short form of the PROMIS consists of 7 self-report items and assesses state anxiety on one scale. A higher score indicates higher anxiety.

13. State anxiety (Time Frame - week 26):
Patient related outcomes measurement information system - anxiety/emotional distress (PROMIS-A/ED) Short form: The A/ED-short form of the PROMIS consists of 7 self-report items and assesses state anxiety on one scale. A higher score indicates higher anxiety.

14. Fear of recurrence (Time Frame - week 12):
The Fear of Relapse/Recurrence Scale (FRRS): The FRRS consists of 5 self-report items and assesses the fear of cancer recurrence on one scale. A higher score indicates higher fear of recurrence.

15. Fear of recurrence (Time Frame - week 26):
The Fear of Relapse/Recurrence Scale (FRRS): The FRRS consists of 5 self-report items and assesses the fear of cancer recurrence on one scale. A higher score indicates higher fear of recurrence.

16. Severity of depressive symptoms (Time Frame - week 12):
Center for epdiemiologic studies depression scale (CES-D): The CES-D consists of 10 self-report items and assesses the severity of depressive symptoms on one scale. A higher score indicates higher severity of depressive symptoms.

17. Severity of depressive symptoms (Time Frame - week 26):
Center for epdiemiologic studies depression scale (CES-D): The CES-D consists of 10 self-report items and assesses the severity of depressive symptoms on one scale. A higher score indicates higher severity of depressive symptoms.

18. Number of patients with adverse events (Time Frame - week 12):
The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)

19. Number of patients with adverse events (Time Frame - week 26):
The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)

20. Total number, type, and grade of adverse events (Time Frame - week 12):
The total number, type and grade of adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)

21. Total number, type, and grade of adverse events (Time Frame - week 26):
The total number, type and grade of adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)

Studien-Arme

  • Experimental: Craniosacral therapy
    24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.
  • Experimental: Craniosacral self-help group training
    24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.
  • Other: Treatment as usual / wait list control
    Waiting period of six months.

Geprüfte Regime

  • Craniosacral therapy:
    The first experimental group of patients will receive 24 units à 45 minutes over 12 weeks (2 consecutive units per week) offered by a trained craniosacral therapist within a 1:1 setting. Treatment as usual is allowed.
  • Craniosacral self-help group training:
    The second experimental group of patients will receive 24 teaching units (TUs) à 45 minutes over 12 weeks offered by a trained craniosacral therapist within a group setting. The group training will start with an introductory day (8 TUs), followed by 6 practice evenings every two weeks (2 TUs each) and a final afternoon (4 TUs). The patients have to agree to participate with a partner (husband, child, friend, etc.) in the introductory day and 90% of the following TUs. All patients will receive a script with theoretical CST information and descriptions of the learned techniques, which should facilitate the correct practice at home. Treatment as usual is allowed.
  • Treatment as usal / wait list:
    The control group will receive no specific study treatment for a waiting period of six months. Treatment as usual is allowed. Afterwards they were offered 2 treatments (4TUS) of 1:1 CST and the participation in the group training.

Quelle: ClinicalTrials.gov


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